ATGAM PACKAGE INSERT PDF

Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There are no adequate and well-controlled studies in pregnant women. It is also not known whether ATGAM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ATGAM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing neonates and infants from ATGAM, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

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Kazrara Advise patients receiving ATGAM that they will be monitored in a facility aygam and staffed with adequate laboratory and supportive medical resources.

The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests. Even if it is stored in a refrigerator, do not exceed a total time in dilution of 24 hours including infusion time. Deep vein thrombosis, Vasculitis Respiratory, thoracic and mediastinal disorders: Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM.

Results from randomized controlled trials in patients with first acute renal allograft rejection episodes refractory to conventional steroid therapy have demonstrated that ATGAM, when administered in conjunction with standard therapy, yields efficacy results superior to those of standard therapy alone.

However, because ATGAM is a gamma globulin product, it can be transparent to slightly opalescent, colorless to faintly pink or brown, and may develop a slight granular or flaky deposit during storage. To identify those at greatest risk of systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment. ATGAM is a transparent to slightly opalescent aqueous protein solution.

Therefore, this toxicity is not considered relevant to human fetal development. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen.

Reversal of acute renal allograft rejection with adjunctive Inserr therapy. ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode [see Clinical Studies Study 3 A total of 53 patients 3 to 76 years of age participated in this randomized, placebo-controlled, double-blind study to determine if androgens add to the efficacy of ATGAM in providing favorable hematologic response rates in patients with moderate to severe aplastic anemia.

Clinical signs associated with anaphylaxis, other infusion associated reactions, and serum sickness have been reported. Patient survival rates were similar in the two treatment groups. Because thrombocytopenia can be associated with the administration of ATGAM, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.

Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain. The range for half-life was 1. The effectiveness of ATGAM for treatment of acute allograft rejection was paciage in three different treatment applications: The effectiveness of ATGAM for reversal of acute renal allograft rejection was also atgamm in other controlled studies performed in various medical centers.

Kidney enlargement, Kidney rupture, Renal failure acute Congenital, familial and genetic disorders: Use of antithymocyte globulin for reversal of acute allograft rejection. Apnea, Cough, Epistaxis, Oropharyngeal pain Gastrointestinal disorders: The results from these studies demonstrate the efficacy associated with the addition of ATGAM to standard therapy for treatment of the first rejection episode in renal allograft recipients.

Trends in immunosuppression for kidney transplantation. Six of the 11 crossover patients from the control group showed improvement after 3 months of therapy. If the subject does not show a wheal ten minutes after pricking, proceed to intradermal testing with 0. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. The maximum tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product.

Improved cadaveric renal transplant outcome in children. Kidney Int ; 13 Suppl 8: Only lots that meet the acceptance criteria for pyrogens and test negative for antihuman serum protein antibody and antiglomerular basement membrane antibody are released. Digital Security Start dosing at the low end of the dosage range. The most commonly reported adverse events were rash, fever, arthralgias, chills, headache, myalgia and pruritus.

Respiratory, thoracic and mediastinal disorders: Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing neonates and infants from ATGAM, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Transplantation ; 28 4: The safety of ATGAM has been evaluated in patients with renal transplant and patients with aplastic anemia. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Pfizer, Inc. A systemic reaction such as a generalized rash, tachycardia, dyspnea, hypotension, or packqge precludes any additional administration of ATGAM.

The objective of this study was to determine the efficacy of ATGAM as a single agent, in restoring hematopoiesis in patients with moderate to severe aplastic anemia. The incidence of toxicologic manifestations did not increase with any of these regimens; however, close monitoring of the patient is recommended.

The effect of ATGAM when administered in conjunction with standard therapy at the time of diagnosis of the first rejection episode was studied under two different protocols with cadaveric and living related renal transplant patients. Serum sickness occurred in all patients within 6 to 18 days of ATGAM initiation and was well-controlled with standard therapy. Aplasia General disorders atyam administration site conditions: Randomized clinical trial of antithymocyte globulin in cadaver renal allograft recipients: For full prescribing information, please visit www.

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Atgam: Package Insert and Label Information

For full prescribing information, please visit www. Apnea, Cough, Epistaxis, Oropharyngeal pain. The maximum tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product. The effectiveness of ATGAM for treatment of acute allograft rejection was evaluated in three different treatment applications: The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share.

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ATGAM PACKAGE INSERT PDF

Mijin Gently rotate or swirl the diluted solution to effect thorough mixing. Advise patients receiving ATGAM that they will be monitored in a facility equipped and staffed with adequate laboratory and supportive medical resources. To identify those at greatest risk, skin testing before treatment is strongly recommended. The effectiveness of ATGAM for reversal of acute renal allograft rejection was also demonstrated in other controlled studies performed in various medical centers. Because clinical trials are conducted under widely varying conditions, inset reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Flank pain, Muscle rigidity, Myalgia, Pain in extremity. A total of 41 patients with moderate or severe aplastic anemia ages 6 to 69 years, who were not candidates for bone marrow transplantation were enrolled in a randomized controlled study.

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